Devices

Device Recall Philips

Model / Serial
159, 183
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US: WA OUS: China, Spain, Korea, Republic of, Germany
Product Description
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Manufacturer
Philips Electronics North America Corporation
1 Event
- Recall of Device Recall Philips

Manufacturer

Philips Electronics North America Corporation

Manufacturer Address
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

229 devices with a similar name

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Device Recall Philips Digital Diagnost VT

Model / Serial
See list above. Site numbers could not be separated by model.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The firm distributed to medical facilities nationwide.
Product Description
Philips Digital Diagnost VT
Manufacturer
Philips Medical Systems Sales & Service Region No. America

Device Recall Philips Healthcare DigitalDiagnost

Model / Serial
software version - 4.0.4, 4.1.2, 4.1.3.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Product Description
Philips Healthcare DigitalDiagnost stationary X-ray system
Manufacturer
Philips Healthcare

Device Recall Philips Healthcare DuraDiagnost

Model / Serial
software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Product Description
Philips Healthcare DuraDiagnost stationary X-ray system
Manufacturer
Philips Healthcare

Device Recall Philips

Model / Serial
Allura Xper with release R8.2,
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam
Product Description
Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; || Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; || Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table, 722039; Allura Xper FD20/15, 722058; Allura Xper FD20/15 OR Table, 722059
Manufacturer
Philips Electronics North America Corporation

Device Recall Philips

Model / Serial
UNIQ with release R1.0
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam
Product Description
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; || UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ FD20/15 OR Table 722059
Manufacturer
Philips Electronics North America Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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